Home / Recalls / Medical Devices
Olympus Corporation of the Americas recalls ViziShot 2FLEX. Single Use Aspiration Needle. Model Number: NA-U403SX-4019. The ViziShot 2 FLEX tissue biopsy device
Recalled September 17, 2025 · FDA recall Z-2484-2025 · Olympus Corporation of the Americas
Hazard
Potential for undetected, deformed a-traumatic tips. · FDA Class I
Units
104,508 units
Sold at
Worldwide distribution - US Nationwide and the countries of Australia, Germany, Canada, Chile, China, Hong Kong, India, Japan, Singapore.
Description
Potential for undetected, deformed a-traumatic tips.
Product
ViziShot 2FLEX. Single Use Aspiration Needle. Model Number: NA-U403SX-4019. The ViziShot 2 FLEX tissue biopsy device is made up of four main parts: a handle, a sheath, a needle, and a stylet. The sheath and needle are attached to the handle, and the stylet, which is removable, is located inside the needle tube.
Manufacturer(s)
Olympus Corporation of the Americas
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →